Enozertinib (ORIC-114)

Aug. 3, 2026: ORIC Pharmaceuticals (NASDAQ: ORIC) reported a catalyst update centered on rinzimetostat and enozertinib. For rinzimetostat in metastatic castration-resistant prostate cancer (mCRPC), ORIC said it finalized the protocol and initiated Himalayas-1, a global Phase 3 registrational trial in patients previously treated with abiraterone. The study is expected to enroll about 600 patients at more than 250 sites in 25 countries, randomizing 1:1 to rinzimetostat 400 mg once daily plus darolutamide versus physician’s choice of an androgen receptor inhibitor or docetaxel; the primary endpoint is radiographic progression-free survival and the key secondary endpoint is overall survival. ORIC also signed a clinical trial collaboration and supply agreement with Bayer, which will provide darolutamide (NUBEQA) at no cost for the trial.

For enozertinib in advanced NSCLC, ORIC said Phase 1b studies are ongoing in first-line EGFR atypical mutation monotherapy, first-line EGFR exon 20 insertion monotherapy, and EGFR exon 20 insertion combinations with subcutaneous amivantamab and with chemotherapy.

Upcoming milestones: rinzimetostat program update in 2H 2026; enozertinib 1L EGFR atypical monotherapy data at ESMO Congress 2026 in October; and 1L EGFR exon 20 insertion monotherapy plus SC amivantamab combination data in 2H 2026.